What to know about setback-plagued Novavax COVID-19 vaccine

Novavax applied for emergency use authorization from the FDA in January, but Tuesday’s convening of the Vaccines and Related Biological Products Advisory Committee will be the agency’s first public meeting about it.

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The vaccine was heralded early on as a promising candidate for regulatory approval in a time when getting a safe and effective COVID-19 vaccine to market was a top priority for the Trump administration. It was one of six candidates backed by former President Donald Trump’s multibillion-dollar initiative Operation Warp Speed, an all-out federal effort to speed the development and distribution of vaccines and treatments for COVID-19. Novavax received a staggering $1.6 billion from the federal government but still hit consistent production snags despite the hefty cash infusion.

Here is what you need to know about the Novavax vaccine and a breakdown of the causes for its delay.

How effective is the vaccine? 

The two-shot vaccine proved in Phase 3 clinical trials to be over 90% effective at preventing infection and 100% effective against symptomatic disease and death. The vaccine has also proven capable of preventing infection due to different strains of the virus. The trial, which took place from late December 2020 through February 2021 in the United States and Mexico, recorded cases caused by the alpha, beta, and gamma variants. Study results published in the New England Journal of Medicine reported that the shots were nearly 93% effective against variants circulating globally in that period.

Novavax has recently launched late-stage trials for its vaccine designed specifically to combat the omicron variant and its offshoots. The vaccine, which has been shown to lose some efficacy when confronted by the omicron variant, has already been licensed in Canada and the European Union. But an FDA analysis released Friday said relevant data to assess the vaccine’s effectiveness against omicron and its sublineages, including observational data from use in other countries, “are currently unavailable.”

“However, based on the efficacy estimate in the clinical trial of this vaccine, it is more likely than not that the vaccine will provide some meaningful level of protection against COVID-19 due to Omicron, in particular against more severe disease,” the FDA’s scientists said.

Why has it taken so long to come to market?

Novavax hit several production hurdles early despite massive government investment in its development. The Maryland-based company had long worked on vaccines for viruses such as MERS, Zika, and Ebola but had never brought one to market. The company had a major new opportunity when COVID-19 cases first became prevalent.

Meeting FDA purity standards

Novavax struggled to meet FDA quality and purity standards early on. Federal regulators typically look for a level of vaccine purity of at least 90%. This ensures that there are few contaminants and outside products in the doses that could cause negative adverse reactions to the shots. Novavax’s purity levels hovered around 70%, according to an October 2021 Politico report.

There were concerns among those familiar with the manufacturing process that the company was incapable of mass-producing a consistently high-quality vaccine. Novavax responded, saying the company has “confidence in our ability to deliver our high-quality vaccine” and has incorporated all of the regulatory agency’s feedback to improve the product.

Manufacturing troubles

Novavax had to scale up its manufacturing infrastructure almost totally from scratch. The company signed deals in 2020 to license and manufacture the vaccines at facilities in the Czech Republic and Sweden, as well as the Serum Institute of India, the world’s largest manufacturer of vaccines. In 2021, the company expanded its manufacturing capabilities to Poland and Canada as well as Texas and North Carolina. The FDA must inspect each of the manufacturing facilities before they begin churning out vaccines to be used in the U.S., which also led to delays in production.

Manufacturing troubles also punted the start of the company’s Phase 3 trials in North America, thus slowing down the company’s application process for FDA authorization. Agency concerns about commercial manufacturing capacity at the Fujifilm Diosynth Technologies North Carolina plant delayed the Phase 3 trial start by about two months, setting the company back significantly when it came to meeting timeline goals for its trial in the U.S.

How does the vaccine work? 

The Novavax vaccine relies on protein-based technology similar to what is used to create the flu, hepatitis B, and shingles vaccines. The process of developing the vaccine is lengthy, however, compounding the problems with speeding up manufacturing capacity.

To develop the vaccine, researchers constructed a spike protein similar to the one on the coronavirus pathogen that binds to cells and infects people. They made the spike protein using insect cells. Specifically, the genetic material used to create the spike protein is developed in the lab and then injected into a virus known as the baculovirus that infects insects. The baculovirus, containing genetic instructions to create the spike protein, infects cells taken from the fall armyworm moth. Scientists then harvest the spike proteins that proliferate in moth cells and filter out the cellular debris. They add a substance to the vaccine nanoparticles called an adjuvant, in this case derived from soapbark tree extract, which turbocharges the immune reaction to the spike protein.

Is the vaccine safe? 

The Novavax vaccine has been deemed safe overall in clinical trials. But FDA officials said Friday that they were concerned about a link between the vaccine and cases of rare heart inflammation. The agency flagged six cases of inflammation conditions known as myocarditis and pericarditis of the roughly 40,000 participants who received doses at different trial sites. FDA scientists said the identification of the six cases “raises concern that if causally associated, the risk of myocarditis following [Novavax vaccination] could be higher than reported during post-authorization use of mRNA COVID-19 vaccines.”

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Will people take it?

Novavax is hoping to reach the niche population of people who have yet to be vaccinated with an mRNA vaccine due to distrust of the technology and/or anxiety about the safety of a vaccine developed at such a rapid pace. The vaccine, if authorized, would also be a suitable alternative for people with allergies to components in the mRNA vaccines.

The technology that the Novavax relies on is considered more traditional than the mRNA technology that Moderna and Pfizer-BioNTech used to create their vaccines. While mRNA technology is not itself new — it has been in development since the 1990s — Pfizer-BioNTech’s mRNA vaccine was the first instance of the technology functioning to create a consistently reliable, safe vaccine. The development of a highly effective mRNA vaccine in less than a year was an unprecedented scientific feat. Many people thought that a truly safe and effective vaccine would take much more time and rounds of trials, just as vaccines for other diseases have, so a vaccine using tried and true technology may be welcome to those skeptical of the original jabs.

Unlike the Novavax shots, the mRNA vaccines depend on the injection of genetic material that teaches the cells to create a blueprint of the spike protein found on the coronavirus, prompting an immune response to the invading pathogens in the event of infection. The prospect of having mRNA injected, no matter how innocuous, spooked many people, convincing them that the Pfizer and Moderna shots were not to be trusted. One of the leading myths about mRNA vaccines that has been debunked numerous times is that the injection of messenger RNA, essentially an instruction manual, will permanently alter a person’s DNA. The mRNA that is injected into a person’s arm is taken up by the cells but does not penetrate the cell’s nucleus, where all DNA exists, making it impossible for the shot to change the structure of the DNA chain.